Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation

Sponsor
Allist Pharmaceuticals, Inc.
Study ID
NCT04858958
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation. The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability. The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902). In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Key Dates

Start date
Aug 10, 2020
Status verified
Mar 2025
Primary completion
Dec 5, 2024
Completion
Feb 28, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treated subjects will receive Furmonertinib 160mg/day,
    treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability.
  • Experimental: treated subjects will receive Furmonertinib 240mg/day,
    treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability.
  • Experimental: treatment-naïve subjects will receive Furmonertinib 240mg/day
    Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC

Primary Outcome Measure

ORR, objective response rate [ Time Frame: up to 12 months ]

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